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NCT05384262
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 in Healthy Subjects
Phase 1 trial testing AZD0780 in Dyslipidemia in 183 participants. Completed in 14 June 2024.
14 June 2024
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 183 |
| Start date | 18 May 2022 |
| Primary completion | 14 June 2024 |
| Estimated completion | 14 June 2024 |
| Sites | 3 locations across United Kingdom, United States |
Drugs / interventions tested
- AZD0780 — full drug profile →
- AZD0780 — full drug profile →
- AZD0780 — full drug profile →
- Placebo
- Placebo
- Placebo
- Rosuvastatin (rosuvastatin) — full drug profile →
Conditions studied
- Dyslipidemia — all drugs for Dyslipidemia →
Sponsor
AstraZeneca — full company profile →
Who can join
Adults 18 to 55, any sex, with Dyslipidemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD0780 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels. This study will consist of two parts (Parts A and B). 56 subjects have been planned for Part A and 141 subjects for Part B. Additional subjects may be included for the optional cohorts depending upon emerging data.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition: The Big Step Forward in Lipid Control.
Rikhi R, Shapiro MD. · · 2023 · cited 5× · PMID 37456766 · DOI 10.15420/ecr.2023.14 -
Emerging therapies for refractory hypercholesterolemia: a narrative review.
Pawlos A, Khoury E, Gaudet D. · · 2024 · cited 2× · PMID 38985520 · DOI 10.1080/14796678.2024.2367860 -
Laroprovstat, the First Oral Small-Molecule PCSK9 Inhibitor for the Treatment of Hypercholesterolemia: Results From a Randomized, Single-Blind, Placebo-Controlled Phase 1 Trial in Treatment-Naive Patients.
Vega RB, O'Mahony G, Barbour AM, Yu H, et al · · 2026 · PMID 42137960 · DOI 10.1161/circulationaha.125.075973
Verify or expand the search:
- PubMed search for NCT05384262
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AZD0780
Trials testing the same drug.
- NCT07423598 — A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics With AZD0780 Following Repeated Dose · Phase 1 · recruiting
- NCT07218900 — A Study to Investigate the Effect of AZD0780 Tablets in Combination With Rosuvastatin Tablets on Low Density Lipoprotein · Phase 2 · recruiting
- NCT07216131 — A Study to Investigate the Effect of AZD0780 on Metformin Pharmacokinetics in Healthy Adult Volunteers Aged 18 to 55 Yea · Phase 1 · completed
- NCT07000136 — A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With HeFH · Phase 3 · active not recruiting
- NCT07000357 — A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a · Phase 3 · recruiting
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Currently open trials in the same condition.
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Other AstraZeneca trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05384262 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
- Last refreshed: 19 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05384262.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing